Clinical Studies

Clinical trials are the basis for the development and marketing of new drugs and medical devices. When studying new chitosan-based medical devices, the necessity of a clinical trial depends on the Class of the medical device and the country of registration (EU/US market). In a clinical trial, participants receive specific interventions according to a research protocol to demonstrate the safety and effectiveness of the device compared to a control (placebo or current standard). Drug studies are performed in phase I to phase IV, while medical device studies are classified as pilot, pivotal and post-approval study. Find out more about currently registered clinical trials with chitosan-based products and outcomes of completed trials in the following articles.